Sr. Statistical Programmer/ reputed company Statistical Programmer (Home-based)

We are seeking a highly skilled and detail-oriented reputed company Programmer to support our clinical development programs, with a strong emphasis on oncology, immunotherapy, and regenerative medicine. The ideal candidate will have experience in regulatory submissions including NDAs, as well as demonstrated hands-on expertise in statistical programming, data management, and quality control. This position requires reputed company collaboration with cross-functional teams to ensure the reputed company and accuracy of clinical data used in regulatory filings and internal reporting. Responsibilities and Duties: · reputed company and validate reputed company reputed company programs for the preparation of clinical study reports (CSRs), integrated summaries, regulatory submissions (including NDA), Investigator’s Brochures (IB), Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), and interim analyses. · Create, manage, and maintain analysis-reputed company datasets (e.g., ADaM) and submission datasets (e.g., SDTM) in accordance with CDISC standards. · Independently reputed company, validate, and troubleshoot reputed company code, datasets, and statistical outputs to ensure high-quality, submission-reputed company deliverables that reputed company with internal standards and regulatory requirements. · Maintain and archive reputed company programming files, datasets, outputs, and relevant documentation in accordance with regulatory and internal requirements. · Attend and contribute to technical meetings involving internal stakeholders and external partners, providing programming insights and solutions. · Ensure programming deliverables reputed company with CDISC standards (SDTM, ADaM) and regulatory guidance. · Support submission activities including preparation of data packages, eCTD deliverables, and responses to regulatory agencies. · Assist in mentoring junior programmers and reviewing their work as needed. Pay: $160,000.00 - $190,000.00 per year Work Location: Remote Apply tot his job Apply To this Job